As the internet shows so clearly, there is great social, technical, and financial benefit in interoperability. The black boxes of proprietary statistical software are starting to give way to more broad and widely accepted transparent open-source standards. Utilization of open-source statistical software in clinical drug development poses unique challenges, some perceived and others real.

The focus of the presented material covers one of the biggest challenges in adoption of this new technology; specifically, determining procedures for the qualification and validation of open-source software. The process often begins with an evaluation on how open-source software will be used in the organization. The benefits, the drawbacks, addressing 21 CFR Part 11 compliance, legal issues, and complex change control / audit trail requirements are some of the most difficult questions faced by potential users of open-source software in the regulated drug development environment.

The topic will be further explored through a case study examining Quintiles experience in evaluating the R open-source software system. Furthermore, the procedures used to qualify and validate the R open-source software system at Quintiles will be illustrated.

Adoption of open-source standards is growing everyday as more individuals find quality, value, frequent updates to, and novel methods in this new software development paradigm. Just as the internet and human genome project revolutionized the technology and genetics sectors, open-source software looks poised to make advances to meet the future needs of clinical drug developers.